Rocbrutinib for adults with relapsed or refractory non‑GCB diffuse large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open‑label, randomized, multicenter Phase II trial compares rocbritinib monotherapy to the investigator's choice of bendamustine plus rituximab (BR) or lenalidomide plus rituximab (R2) in adults with relapsed or refractory non‑GCB DLBCL. Eligible participants are age 18 or older with pathologically confirmed non‑GCB subtype who have failed at least two prior lines of therapy including an anti‑CD20 regimen and have at least one measurable lesion. Patients are randomized to receive oral rocbritinib or the selected comparator regimen and are followed for response, progression, and safety outcomes. Pathology confirmation requires available tumor tissue or slides, and the study is being conducted at multiple centers in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years, any gender.
2. Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report).
3. Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed).
4. At least one measurable lesion (nodal lesion with longest diameter \>1.5 cm, extranodal lesion with longest diameter \>1.0 cm).
5. Not planned for autologous stem cell transplantation (ASCT).
6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.

Exclusion Criteria:

1. Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission).
2. DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma \[such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.\] or pathological findings suggesting concomitant FL (any grade).
3. Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc.
4. Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients.
5. Previous refractoriness to BTK-targeting drugs.
6. Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.

Where it's running

• National Cancer Center/Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital)
  Hefei, Anhui, China Not yet recruiting
• Beijing Shijitan Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Tongren Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Yuankai Shi
• Email: syuankaipumc@126.com
• Phone: 86+010-87788293

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.